OSE Immunotherapeutics SA and Servier announced the execution of an amendment to the two-step global licensing option agreement for exclusive global rights to interleukin-7 receptor (IL-7R) antagonist OSE-127. In particular, the amendment modifies the provisions regarding the option exercise modalities and associated financial conditions.
Under this amendment, OSE Immunotherapeutics and Servier have agreed to modify the provisions regarding the potential exercise of the option, amending step 2 of the option agreement, making OSE eligible to receive a €5 million milestone payment from Servier upon the enrollment of the first patient in the Phase 2a clinical study in Sjögren’s syndrome and an additional €15 million payment upon exercise option completion of both Phase 2 clinical trials, and in priority upon completion of the Phase 2a clinical study in Sjögren’s syndrome. The previous version of the agreement had the full €20 million milestone payment due upon completion of Phase 2 clinical study in Ulcerative colitis.
Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, said: “We are very pleased with the terms of this amendment, further demonstrating Servier’s commitment and strong belief in the potential of OSE-127, as a potential best-in-class treatment for autoimmune conditions. This milestone payment associated with this amendment, in line with our business model, will reinforce our cash position. The encouraging Phase 1 results with OSE-127 showing a good safety and tolerability profile for the product, together with a novel and differentiated mechanism of action as the only full-antagonist of IL-7R, support the potential of this compound to be an important therapy for patients suffering from Sjögren’s syndrome or ulcerative colitis, both debilitating autoimmune diseases. We look forward to evaluating the product’s efficacy in these indications through the two independent Phase 2 studies expected to be initiated this year.”
Claude Bertrand, Executive Vice-President Research & Development at Servier, said: “We are very pleased with the progress already achieved on OSE-127’s program. Having two Phase 2 clinical trials to start this year is a significant milestone in R&D. Our collaboration with OSE will contribute to the acceleration of the development of therapeutic solutions for patients suffering from auto-inflammatory diseases with very strong medical needs.”
Under the terms of the initial agreement signed in December 2016, OSE Immunotherapeutics granted Servier a two-step option agreement to acquire the exclusive worldwide license to develop and commercialize OSE-127 until the completion of a Phase 2 clinical trial planned in ulcerative colitis, an autoimmune bowel disease. OSE is eligible to receive up to a total of €272 million in development, regulatory and sales milestones. The €272 million include the upfront payment of €10.25 million, received in early 2017, and additional payments of up to €30 million to be paid upon the exercise of the initial two-step option, including €10 million paid upon exercise of the first option step and received in early 2019. Based on the positive Phase 1 results with OSE-127, two independent Phase 2 clinical studies are expected to start in 2020: in Sjögren’s syndrome, under Servier sponsorship, and in ulcerative colitis, under OSE sponsorship. Under the current amendment, the second option provides a €5 million milestone payment upon enrollment of the first patient in the Phase 2a clinical study in Sjögren’s syndrome and a €15 million milestone payment upon completion of both Phase 2 clinical studies and exercise of the option, in priority upon successful completion of the Phase 2 in Sjögren’s syndrome.